General Questions
Need senior medical input before your next study, board meeting, launch milestone, or content review? Contact Gisselbaek Consulting for a focused discussion.
What does Gisselbaek Consulting do?
Gisselbaek Consulting provides senior medical, clinical development, and Medical Affairs support for international biotech, medtech, and small pharma companies. The company helps organisations strengthen clinical development strategy, study design, Medical Affairs operating models, and medical/scientific content review.
Who does Gisselbaek Consulting typically work with?
Gisselbaek Consulting works with early- and mid-stage biotech companies preparing or running clinical trials, medtech and device companies building clinical evidence, smaller pharma and specialty pharma companies needing senior medical capacity, and investors or boards seeking an independent clinical and medical perspective.
When should a biotech company bring in senior medical leadership?
A biotech company should consider senior medical leadership when the clinical programme becomes too complex for the existing team, when protocols and investor milestones need to align, when regulatory interactions are approaching, or when the company needs one person to hold the full clinical and medical development picture together. Your LinkedIn material frames this as the moment when the pipeline grows faster than the internal medical leadership structure.
How does Gisselbaek Consulting help create value in biotech and pharma development?
Gisselbaek Consulting helps companies connect clinical strategy, evidence generation, risk, governance, and capital allocation. The central idea is that clinical development is not only a cost centre or operational function, but a value engine where study design, decision quality, and risk architecture directly affect enterprise value.
What makes Gisselbaek Consulting different from a CRO?
A CRO typically supports operational execution of clinical studies. Gisselbaek Consulting supports the strategic medical and clinical decisions behind the programme: what evidence is needed, how studies should be designed, how risks should be structured, how the development story supports investors and regulators, and how Medical Affairs can translate evidence into trust, access, and adoption.
Fractional CMO / Medical Director Questions
Need senior medical input before your next study, board meeting, launch milestone, or content review? Contact Gisselbaek Consulting for a focused discussion.
What is a fractional CMO or fractional Medical Director?
A fractional CMO or Medical Director is a part-time senior medical leader who supports a biotech, medtech, or small pharma company without the company needing to hire a full-time Chief Medical Officer. Typical responsibilities include clinical development strategy, study portfolio oversight, regulatory medical input, support for investor and board discussions, and mentoring of internal clinical or medical teams.
When is a fractional CMO the right solution?
A fractional CMO is often the right solution when a company needs senior medical leadership but is not yet ready for a full-time CMO. This is common when a biotech is preparing a first-in-human study, moving toward proof of concept, managing multiple external partners, preparing for investor meetings, or building the next 12–24 months of clinical development strategy.
How can a fractional CMO support investor discussions?
A fractional CMO can help connect the clinical development plan with the investment story. This means defining which evidence is needed for the next financing round, clarifying clinical inflection points, stress-testing assumptions, and ensuring the protocol, evidence plan, and funding narrative tell one coherent story.
Can Gisselbaek Consulting support boards and executive teams?
Yes. Gisselbaek Consulting can provide independent medical and clinical input to boards, investors, and executive teams. This can include assessment of clinical strategy, review of development assumptions, risk assessment, interpretation of clinical data, and advice on whether the programme is structured to support value creation or value realisation.
How many days per week does a fractional CMO engagement usually require?
A typical engagement is flexible and often ranges from one to three days per week, depending on the company’s stage, complexity, and internal resources.
Clinical Development & Study Design Questions
Need senior medical input before your next study, board meeting, launch milestone, or content review? Contact Gisselbaek Consulting for a focused discussion.
How does Gisselbaek Consulting support clinical development strategy?
Gisselbaek Consulting supports clinical development strategy by reviewing the asset, data package, indication logic, endpoints, comparators, patient population, risk areas, timelines, and decision points. The goal is to ensure that the next study is not only scientifically sound, but also feasible, fundable, interpretable, and aligned with regulatory, payer, clinical, patient, and investor expectations.
Why is early clinical study design so important?
Early clinical study design matters because the first studies shape the entire evidence story. A first-in-human or proof-of-concept study should not only answer a narrow safety or efficacy question; it should generate data that supports future regulatory decisions, payer confidence, clinical adoption, and investor value creation.
How does Gisselbaek Consulting help with clinical development decision-making?
Gisselbaek Consulting helps companies clarify decision ownership, governance, risk placement, and milestone logic. Clinical development is not only a sequence of studies; it is also a decision system where choices about stopping, expanding, focusing, or interpreting data directly shape value.
What does “Next Study Ready” mean?
“Next Study Ready” means that the next clinical study has been stress-tested before major resources are committed. This includes reviewing the data package, development assumptions, indication choice, endpoints, patient population, comparators, feasibility, risks, timelines, and the role of the study in the broader development and investment story.
How can study design affect biotech valuation?
Study design affects biotech valuation because each readout is both a medical milestone and a financing event. In venture-stage biotech, a study must often generate evidence that is scientifically credible and strong enough to support the next investment decision.
What is the difference between explorative and decisive clinical readouts?
Explorative readouts are designed to learn, reduce uncertainty, and guide the next step. Decisive readouts are designed to confirm, drive valuation, and trigger major decisions. Treating an explorative study as if it were decisive can create unnecessary binary risk and may damage the value story even when the underlying data are scientifically promising.
How can Phase III study design reduce the risk of failure?
Phase III study design can reduce avoidable failure risk by focusing on data quality, realistic power assumptions, appropriate patient selection, minimising confounders, controlling protocol complexity, and ensuring that endpoints and procedures create a fair and interpretable test of the treatment. Your own material makes the point that sometimes the trial fails the drug, rather than the drug failing the trial.
Medical Affairs Strategy & Organisation Questions
Need senior medical input before your next study, board meeting, launch milestone, or content review? Contact Gisselbaek Consulting for a focused discussion.
What is Medical Affairs strategy?
Medical Affairs strategy defines how the medical function creates value for the organisation. It clarifies priorities, evidence gaps, stakeholder needs, scientific narrative, KOL engagement, publication planning, MSL activities, insight generation, and how Medical Affairs supports corporate strategy, access, adoption, and trust.
When does a company need help building its Medical Affairs function?
A company may need help when Medical Affairs has become reactive, fragmented, or unclear in its mandate. Warning signs include ad hoc requests, late-stage content review, unclear medical–commercial boundaries, disconnected KOL plans, Excel-based evidence planning, or a first medical hire who is expected to invent the function alone.
How should Medical Affairs and Commercial work together?
Medical Affairs and Commercial should collaborate through clear governance, defined roles, transparent content workflows, and a shared understanding of scientific exchange versus promotion. The goal is to avoid both extremes: Medical being too close to promotional work or too distant and perceived as a blocker.
What is the difference between a Medical Affairs plan and an activity list?
An activity list contains tasks such as advisory boards, congress activities, publications, MSL visits, and KOL engagement. A true Medical Affairs plan links these activities to medical priorities, evidence gaps, stakeholder needs, launch or lifecycle milestones, and corporate strategy.
How does Medical Affairs create value?
Medical Affairs creates value by translating scientific evidence into external confidence, clinical relevance, access readiness, stakeholder trust, and better internal decisions. It should not only collect insights or run activities; it should help the company understand what evidence matters, what experts believe, what gaps remain, and what decisions should change.
How can Medical Affairs support launch readiness?
Medical Affairs supports launch readiness by identifying evidence gaps, mapping stakeholders, preparing the scientific narrative, understanding local treatment pathways, anticipating payer and clinician questions, and building scientific confidence before and after approval. Approval does not automatically create access, adoption, or physician conviction.
Can Gisselbaek Consulting support Medical Affairs teams at both headquarters and affiliate level?
Yes. Gisselbaek Consulting can support Medical Affairs at both headquarters and affiliate level. HQ Medical Affairs often creates value by shaping the scientific narrative, evidence synthesis, and communication platform, while affiliate Medical Affairs creates value by translating that evidence into local relevance, stakeholder understanding, and clinical reality.
Medical Review & Scientific Content Validation Questions
Need senior medical input before your next study, board meeting, launch milestone, or content review? Contact Gisselbaek Consulting for a focused discussion.
What is medical review and scientific content validation?
Medical review and scientific content validation is an independent assessment of promotional and non-promotional materials to ensure that scientific claims are accurate, balanced, evidence-based, and aligned with relevant compliance frameworks and codes of practice.
What types of materials can Gisselbaek Consulting review?
Gisselbaek Consulting can review promotional and non-promotional materials, scientific decks, medical education content, field medical materials, investor or board-facing clinical summaries, publication-related materials, and other scientific content where medical accuracy, balance, and claim substantiation are important.
Why is independent medical review important?
Independent medical review helps reduce the risk of inaccurate claims, weak substantiation, overstatement of data, inconsistent scientific messaging, and compliance issues. It also helps companies maintain credibility with healthcare professionals, payers, regulators, internal stakeholders, and external partners.
How can smaller pharma or biotech companies structure medical review without a large internal team?
Smaller companies can use a flexible model such as a retainer, hour bank, or project-based review process. This gives access to senior medical review capacity without building a large permanent function. Your company deck already positions medical review as available through retainer, hour bank, or project-based support.
How is medical review connected to Medical Affairs strategy?
Medical review should not be an isolated late-stage approval step. It works best when connected to Medical Affairs strategy, scientific narrative, evidence planning, content governance, and medical–commercial collaboration. This helps ensure that materials are not only compliant, but also scientifically coherent and aligned with the company’s broader value story.